FDA Application
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NDC Search Results on Active Ingredient: acetaminophen
Click on Active Ingredient to view the label.
Ingredient Name | NDC | Company Name | Application Number or Regulatory Citation | Product Type | Marketing Category |
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HYDROCODONE BITARTRATE; ACETAMINOPHEN | 50268-402-11 | AvPAK | ANDA040736 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 50268-402-15 | AvPAK | ANDA040736 | HUMAN PRESCRIPTION DRUG | ANDA |
HYDROCODONE BITARTRATE; ACETAMINOPHEN | 50268-400-15 | AvPAK | ANDA040746 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 50268-052-15 | AvPAK | ANDA076200 | HUMAN OTC DRUG | ANDA |
BUTALBITAL; ACETAMINOPHEN; CAFFEINE | 50268-553-11 | AvPAK | ANDA209587 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 50268-644-15 | AvPAK | ANDA040777 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE | 50268-401-11 | AvPAK | ANDA040736 | HUMAN PRESCRIPTION DRUG | ANDA |
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN | 50268-645-15 | AvPAK | ANDA040778 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 83314-111-11 | A-Z Pharma Group LLC | part343 | HUMAN OTC DRUG | OTC monograph not final |
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN | 82577-967-22 | B&W Pharmaceuticals Inc. | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
ACETAMINOPHEN | 0264-4050-90 | B. Braun Medical Inc. | NDA204957 | HUMAN PRESCRIPTION DRUG | NDA |
ACETAMINOPHEN | 0264-4100-90 | B. Braun Medical Inc. | NDA204957 | HUMAN PRESCRIPTION DRUG | NDA |
ACETAMINOPHEN | 0264-4050-80 | B. Braun Medical Inc. | NDA204957 | HUMAN PRESCRIPTION DRUG | NDA |
ACETAMINOPHEN | 63162-510-12 | Ballay Pharmaceuticals, Inc | part343 | HUMAN OTC DRUG | OTC monograph not final |
BUTALBITAL; ACETAMINOPHEN | 0095-3000-01 | Bausch Health US, LLC | ANDA090956 | HUMAN PRESCRIPTION DRUG | ANDA |
BUTALBITAL; ACETAMINOPHEN | 0095-3000-09 | Bausch Health US, LLC | ANDA090956 | HUMAN PRESCRIPTION DRUG | ANDA |
ACETAMINOPHEN | 36000-306-60 | Baxter Healthcare Corporation | ANDA214331 | HUMAN PRESCRIPTION DRUG | ANDA |
PYRILAMINE MALEATE; ACETAMINOPHEN; CAFFEINE | 0280-8015-24 | Bayer HealthCare LLC | M027 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; ASCORBIC ACID; CHLORPHENIRAMINE MALEATE | 0280-0046-05 | Bayer HealthCare LLC | HUMAN OTC DRUG | Export only | |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; DOXYLAMINE SUCCINATE; ACETAMINOPHEN | 11523-0026-1 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE | 0280-0095-02 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN | 0280-1600-20 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE | 0280-0921-06 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE | 11523-0038-2 | Bayer HealthCare LLC. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 0280-0088-02 | Bayer HealthCare LLC. | part341 | HUMAN OTC DRUG | OTC monograph final |
ACETAMINOPHEN; GUAIFENESIN | 11523-0094-1 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 0280-1580-20 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE | 0280-0092-01 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE | 0280-0151-02 | Bayer HealthCare LLC. | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 0280-0055-01 | Bayer HealthCare LLC. | part341 | HUMAN OTC DRUG | OTC monograph final |
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